Wound closure apparatus and method

ABSTRACT

Apparatus for suturing a wound in a body cannula having an axis extending between a proximal end and a distal end. A handle is disposed at the proximal end and a pair of needles disposed at the distal end, the needles being movable between a proximal position and a distal position. A suture manipulator carried by the cannula is insertable through the wound and operable to manipulate the suture into an engaging relationship with the needles on the far side of the body wall. A finger tab is movable on the handle in a single distal direction through multiple stage. In a first stage the needles are deployed; in a second stage, the suture manipulator is activated to thread the needles; and in a third stage the suture is released from a tensioning mechanism. In an associated method the needles are threaded on the far side of the body wall and withdrawn from the wound providing access to the suture ends on the near side of the body wall. Tying the suture ends closes the wound.

This is a continuation of application Ser. No. 08/502,482 filed Jul. 14,1995 now U.S. Pat. No. 5,700,273.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to apparatus and methods for closing awound or hole in a body wall, and more specifically to wound closuredevices using suture material.

2. Discussion of the Prior Art

A puncture-type wound in a body wall can be created eitherunintentionally, or intentionally as part of a surgical procedure. Ineither case, the wound typically has the configuration of a holeextending through the body wall where access to the far side of the wallis available only through the wound.

The wound in the body wall may be accidentally created but it is morelikely that it will be intentionally created in a surgical procedureassociated with interventional cardiology, for example.

Surgical procedures involving interventional cardiology commonly producea wound in the femoral or iliac artery of the patient. In this case, thebody wall in which the wound is formed is the wall of the artery whichis disposed some distance beneath the skin of the patient. When thesearteries are punctured, wounds or holes are left in the tissue wallforming the arteries. Currently, large caliber access sheaths anddilators are used which merely accentuate the size of the wound anddemand an appropriate suturing apparatus and technique for closing thewound. Wounds of this type have been addressed with direct hand pressureor specialized weights, bandages and dressings. These implements,requiring placement for extended supervised periods of time, also resultin considerable discomfort to the patient. Other types of closuredevices include bioresorbable plugs which in some cases provide a matrixwhich facilitates clotting. More recently, devices have been used whichinclude needles and attached sutures which have been inserted into thevessel. The needles have been driven outwardly through the wall of thevessel where the suture ends have been captured and retrieved for knottying.

Similar devices are represented by U.S. Pat. No. 5,417,699 whichdisclose a pair of proximally facing needles insertable through thewound and radially expandable so that upon retraction of the device theneedles extend through holes in the surrounding tissue. The prethreadedholes are then drawn outwardly through the tissue wall along with theends of attached sutures. This construction requires a special needlecapture mechanism to pull the needles proximally through the body wall.

SUMMARY OF THE INVENTION

The wound closure device of the present invention includes a distalcannula which is insertable through the wound and functions to provide asuture on the far side of the body wall. A handle of the device remainson the near side of the body wall. A finger tab operable on the handlemanipulates the suture on the far side of the body wall between radiallyspaced outer and inner positions. A needle deployment mechanism, alsooperable on the handle, deploys needles from a proximal position to adistal position. In the distal position, the needles extend throughneedle holes in the surrounding tissue of the body wall, and intoproximity with the suture on the far side of the body wall. In thisposition, the needles are disposed between the first and secondpositions of the suture so that manipulation of the suture between thefirst and second positions results in engaging the needle. The needlescan then be withdrawn to capture the ends of the suture and to bringthose ends through the needle holes to the near side of the body wall.At this point, the entire wound closure device can be retracted leavingthe suture ends extending through tissue on opposite sides of the wound.Tying a knot between these ends tightens the suture across the wound toaccomplish closure.

The apparatus for threading the needle on the far side of the body wallcan include a Mallicot structure legs which is radially expandable andcontractible to move the suture into threading engagement with theneedles. This mechanism is operable from the handle of the apparatus onthe near side of the body wall.

Apparatus for deploying the needles between the proximal and distalpositions is also operable from the handle. This apparatus not onlymoves the needle but also trips the threading mechanism when the needlesare appropriately positioned for threading. Further operation of thedeployment mechanism frees the suture loop from a tensioning mechanismafter the needles have been threaded, thereby permitting the apparatusto be withdrawn from the wound with the suture appropriately positionedto facilitate closure of the wound.

In one aspect of the invention, a wound closure apparatus is adapted forsuturing a wound in a tissue wall. The apparatus includes a cannulahaving an axis extending between a proximal end and a distal end. Ahandle is disposed at the proximal end of the cannula. At least one pairof needles is disposed in proximity to the distal end of the cannula,the needle being movable between a proximal position and a distalposition wherein the needle extends through the tissue wall. A suturemanipulator carried by the cannula is insertable through the wound andoperable to manipulate the suture into an engaging relationship with theneedle when the needle is in the distal position.

An associated method results in suturing a wound formed in tissue of abody wall having a near side and a far side. Steps of the method includeproviding a suture having a first end, a second end, and a suture loopextending therebetween. The first and second ends of the suture areinserted through the wound leaving the suture loop on the near side ofthe body wall. Inserting an unthreaded first needle and an unthreadedsecond needle through the tissue places the distal ends of the needleson the far side of the body wall. The method also includes the steps ofthreading the first and second needles on the far side of the wall withrespective ends of the suture, and withdrawing the threaded needlestogether with the associated first and second ends of the sutures to thenear side of the body wall. Then the suture ends can be tensioned todraw the suture loop to the far side of the body wall, and tied to drawthe tissue into proximity and thereby close the wound in the body wall.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view of a patient and illustrating oneembodiment of a wound closure apparatus of the present invention beingused to close a wound in the femoral artery of the patient;

FIG. 2 is a front elevation view of one embodiment of the wound closureapparatus illustrated in FIG. 1;

FIG. 3 is an axial cross section view of the apparatus taken along lines3--3 of FIG. 2;

FIG. 3A is a radial cross section view taken along lines 3A--3A of FIG.3;

FIG. 3B is a radial cross section view taken along lines 3B--3B of FIG.3;

FIG. 3C is a cross-section view of a suture tensioning mechanism takenalong lines 3C--3C of FIG. 3;

FIG. 3D is a cross-section view of the suture tensioning mechanismillustrated in FIG. 3C, the mechanism being deactivated to release thesuture;

FIG. 4 is an axial cross section view similar to FIG. 3 and showing oneembodiment of a suture deployment mechanism associated with the presentinvention;

FIG. 5 is an axial cross section view similar to FIG. 4 and showing oneembodiment of a needle deployment mechanism associated with the presentinvention, the needle mechanism being illustrated in a distal positionsuitable for threading the needles;

FIG. 5A is a radial cross-section view taken along lines 5A--5A of FIG.5, and showing the suture deployment mechanism in an expanded stateprior to threading;

FIG. 5B is a radial cross-section view similar to FIG. 5A and showingthe suture deployment mechanism in a radially contracted state with thesuture tightly held against the needles for threading;

FIG. 6 is an axial cross section view similar to FIG. 5 and showing theneedles in a retracted position after being threaded;

FIG. 6A is an enlarged view of the threaded needles in the retractedposition illustrated in FIG. 6;

FIG. 7 is a side elevation view illustrating the wound closure apparatusfully removed from the wound with the suture ends extending through thesurrounding body wall;

FIG. 8 is a side elevation view of the suture ends tied to close thewound in the body wall;

FIG. 9 is an end view similar to FIG. 5A and showing an alternateorientation of the suture to facilitate the threading of needles in anembodiment suitable for forming more than one pair of needle holes;

FIG. 10 is an elevation view of a further embodiment of the apparatusincluding two pairs of needles; and

FIG. 11 is an elevation view of the wound closure apparatus beingrotated so that a single pair of needles creates more than one pair ofneedle holes.

FIG. 12 is a side elevation view of a further embodiment of a woundclosure apparatus including a pair of suture capture needles.

DESCRIPTION OF PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION

A wound closure apparatus is illustrated in FIG. 1 and designatedgenerally by the reference numeral 10. The apparatus 10 is illustratedin use for closing a wound 12 in a femoral artery 14 of a patient 16.The wound 12 would typically have been intentionally created in order toprovide access through the femoral artery 14 to the cardiovascularsystem of the patient 16. In this case, the wound 12 is formed in thetissue of a body wall which forms the femoral artery 14. Thus, portionsof the femoral artery define the hole or wound 12 in the body wall. Theapparatus 10 is typically introduced into the artery 14 over a guidewire18 which extends through an incision 21 in the skin 23 of the patient16.

It will be understood that although FIG. 1 illustrates the suturing of awound 12 interiorly of the skin 23, the apparatus 10 is equally adaptedfor use in suturing a wound in any body wall including the skin 23.

A preferred embodiment of the wound closure apparatus 10 is illustratedin FIG. 2 and consists generally of a cannula 30 having a distal section32, a proximal section 34, and an intermediate section 36. In thisparticular embodiment, the proximal section 34 comprises a handle 37,the distal section comprises a flexible catheter 45, and theintermediate section 36 comprises a generally rigid tube. The cannula 30is otherwise defined by an axis 38 which extends between a proximal end41 and a distal end 43 of the apparatus 10.

The cannula 30 is generally hollow in order to facilitate insertion ofthe apparatus 10 over the guidewire 18 which is shown at both theproximal and distal ends 41 and 43 respectively. Graduations 47 can beprovided on the exterior surface of the intermediate section 36 in orderto measure the depth of the wound 12 relative to the skin 23. Radiopaquemarker rings can also be provided on the catheter 45 to facilitatefluoroscopic guidance and X-ray contrast.

The handle 37 includes a pair of stationary finger rings 52, and anactuator in the form of an axially movable finger ring 54 which isdiscussed in greater detail below. A finger tab 56 is also movable alongthe handle 37. This finger tab 56 rides within an elongate groove 58which includes a slot 61 having a proximally facing shoulder 63. Theembodiment of FIG. 2 is also provided with a Touhy-Borst valve 65 whichcan be tightened to seal against the guidewire 18. Backbleeding throughthe catheter 45 can be evidenced through the Touhy-Borst valve 65 toprovide a visual indication that the catheter 45 is located within theartery 14.

The interior regions of the cannula 30 are illustrated in FIG. 3. Fromthis view it can be seen that the catheter 45 in this particularembodiment extends from the proximal end 41 and exits the cannula 30through the distal end 43. Thus the catheter 45 forms a hollow tubewithin the hollow tube of the cannula 30. An inner channel 70 associatedwith the catheter 45 is adapted to receive not only the guidewire 18,but also a suture 72 which is described in greater detail below. Aninner channel 74 associated with the cannula 30 is provided with a plug76 at its distal end 43. This plug 76 has a distally facing outersurface 78, a proximally facing shoulder 79, and an annular recess 81terminating within the channel 74 at a proximally facing surface 83.Radially outwardly of the recess 81, a pair of longitudinal needle bores85, 87 are provided which extend generally parallel to the axis 38 fromthe cannula channel 74 to the outer surface 78.

A pair of needles 90, 92 are mounted for reciprocal movement within therespective bores 85 and 87. These needles 90, 92 are carried by a commonradial flange 94 which is disposed within the channel 74 of the cannula30 but is suitably apertured to receive the catheter 45 along the axis38. On the distal side of the flange 94, a needle return spring 96 isdisposed to extend from the surface 83 of the recess 81 to the flange94. On the proximal side of the flange 94, a travel slack spring 98extends from the flange 94 to a distally facing surface 101 of anelongate cylinder 103. This cylinder 103, which is disposed coaxial withand interiorly of the cannula 30, and is moveable by operation of thefinger ring 54 within the channel 74 of the cannula 30. The catheter 45extends through the cylinder 103 so that the cylinder 103 occupies agenerally cylindrical space between the catheter 45 and the cannula 30.

In this embodiment of the wound closure apparatus 10, the finger ring 54and attached cylinder 103 together with the springs 96, 98, the needles90, 92 and associated flange 94 function as a deployment mechanism toinitially deploy and ultimately retract the needles 90, 92. As thefinger ring 54 is moved distally, the surface 101 of the cylinder 103presses against the spring 98 which in turn forces the flange 94 andattached needles 90, 92 distally against the bias of the spring 96.Thus, distal pressure on of the finger ring 54 moves the needles 90, 92from a proximal position best illustrated in FIG. 3 to a distal positionbest illustrated in FIG. 5.

When the finger ring 54 is moved backwardly or proximally, the cylinder103 withdraws from the spring 98 and the force of the compressed springon the flange 94 causes the needles 90, 92 to return from the distalposition illustrated in FIG. 5 toward the proximal position illustratedin FIG. 3. The combination of the cylinder 103 and finger ring 54 isalso provided with a trip mechanism in the form of a tang 105 whichrides within the groove 58 to engage a flange 107 on the finger tab 56.This flange 107 has an inclined surface 109 and a distal facing shoulder111, discussed in greater detail below.

A suture deployment mechanism 114 can be formed as part of the catheter45 in general proximity to the distal surface 78 associated with thecannula 30.

In a preferred embodiment, this suture manipulating mechanism 114 isformed by a plurality of slits 116 (best shown in the radial crosssection view of FIG. 3B) which are spaced around the circumference ofthe catheter 45. These slits 116 define a plurality of fingers 118perhaps best shown in FIG. 5A. Each of the fingers 118 can be providedwith an intermediated living hinge 121 which facilitates radialexpansion of the fingers 118 when the catheter 45 is axially compressed.This radial expansion occurs between a first position illustrated inFIG. 3, where the fingers 118 have a relatively low profile, to a secondposition illustrated in FIG. 4, where the fingers 118 have a relativelyhigh radial profile. In combination, the expandable fingers 118 form adevice commonly referred to as a Mallicot structure. Between the first,low profile position and the second, high profile position of thefingers 118, there exists a natural position described below withreference to FIG. 6.

The suture manipulating mechanism 114 also includes the finger tab 56and a projection 123 which extends from the tab 56 through the groove 58and into the channel 74 of the cannula 30. An elongate element 125 isfixed at its proximal end to the a projection 123 and at its distal endto a flange 127 at the distal tip of the apparatus 10. This flange 127,which is apertured to receive the guidewire 18, is at least as large asthe catheter 45 at the distal end 43 of the apparatus 10. It is thepurpose of the finger tab 56, the element 125 and the flange 127 to movethe fingers 118 between the low profile position and the high profileposition. As the finger tab 56 is moved proximally, from the solid lineposition to the dotted line position in FIG. 3, the element 125 istensioned thereby drawing the distal flange 127 proximally. This createsan axial compression force on the catheter 45 which causes each of thefingers 118 to buckle at its ends and at the associated living hinge 21thereby resulting in expansion of the finger 118 forming the Mallicotstructure.

These fingers 118 can be maintained in the second, expanded positionautomatically by ensuring that the flange 107 associated with the fingertab 56 is appropriately lodged within the slot 61 associated with thegroove 58. Thus, the finger tab 56 can be locked in the proximal, dottedposition when the flange 107 falls into the slot 61 and the distallyfacing surface 111 of the flange 107 engages the proximally facingsurface 63 of the slot 61. The resulting lock, which holds the tab 56 inits proximal position and holds the fingers 118 in their second expandedstate, is released in a preferred embodiment when the tab 105 associatedwith the finger ring 54 and cylinder 103 engages the flange 107 forcingit out of the slot 61. When the lock is released, it is the naturaltendency of the fingers 118 to move back toward the low profile state.This forces the distal flange 127 distally tensioning the element 125and drawing the finger tab 56 distally, from the dotted position to thesolid line position in FIG. 3. Distal finger pressure on the tab 56 canalso facilitate movement of the fingers 118 from the high profile statetoward the low profile state if the elongate element 125 can accommodatea compressive load.

This operation of the suture manipulating mechanism 114 and theexpandable fingers 118 make this structure particularly useful indeploying the suture 72. As best illustrated in FIGS. 3 and 4, thesuture 72 includes free ends 130 and 132 which can be embedded in ornear the living hinge 121 of adjacent fingers 118. Between the ends 130and 132, the suture forms a suture loop 134 which is relatively long andextends from the fingers 118 into the channel 70 of the catheter 45 andalong substantially the entire length of the cannula 30 where it exitsthe catheter 45 through a pathway or hole 136.

Exteriorly of the catheter 45, the suture loop 134 engages a suturetensioning device 138 in the form of a tab 141 formed in the wall of thecylinder 103. This tab 141 includes a post 143 which extends radiallyoutwardly to receive the suture loop 134. The tab 141 is compressibleradially inwardly by a projection 145 on the inner surface of the handle37. As the cylinder 103 moves axially, by operation of the finger ring54, the projection 145 engages the tab 141 and moves it radiallyinwardly. This causes the suture 72 to clear the post 143 effectivelydislodging the suture loop 134 from the tensioning device 138. Thisfeature is particularly advantageous during operation of the apparatus10 for reasons discussed in greater detail below.

A preferred method for attaching the suture 72 to the fingers 118 can bebest understood with reference to FIG. 5A. In this embodiment, thefingers 118 are further designated by the reference numerals 152, 154,156, and 158. In the view of FIG. 5A, the fingers 152-158 are fullyextended in the second position. The associated living hinges 121 aredisposed at the bends of the fingers 152-158 where the fingers reachtheir maximum radial distance from the axis 38.

With such an embodiment, the suture end 130 can be loosely embedded inthe finger 154, the suture can then be led from the finger 154 andthrough a slit in the living hinge 121 associated with the finger 156.From this point, the suture loop 134 can be fed into the catheter 45 andalong the length of the cannula 30. In a similar manner, the suture end132 can be loosely embedded in the finger 152 and led through a slit inthe living hinge 121 associated with the leg 158. With this orientation,each of the suture ends 130, 132 forms a short section of suture whichextends between adjacent legs. Thus, the suture end 130 extends betweenadjacent legs 154, 156 to form a suture portion 159, while the sutureend 132 extends between opposing adjacent legs 152, 158 to form a sutureportion 160.

Loading of the wound closure apparatus 10 can be accomplished during thefinal stage of manufacture. The finger tab 56 on the handle 37 isinitially set to the distal position illustrated by the solid lines inFIG. 3. This ensures that the fingers 118 forming the Mallicot structureare in the low profile state. The suture 72 can then be mounted on thefingers 118 and the suture loop 134 and threaded through the channel 70of the catheter 45. After exiting the hole 136 in the catheter 45, thesuture loop 134 is disposed around the post 143 in the suture tensioner138. Finally, the movable finger ring 54 is placed in its proximalposition so that the needles 90, 92 are retracted into the associatedbores 85, 87. The Touhy-Borst valve 65 can also be to loosened to allowinsertion over the guidewire 18.

Operation of the wound closure apparatus is begun by inserting thecatheter 45 into the wound 12. If the wound 12 is in the skin 23 of thepatient 16, the catheter 45 is introduced directly into the wound 12. Ifhowever, as illustrated in FIG. 1, the wound occurs in a body wall, suchas the wall of the femoral artery 14, the small incision 21 can be madein the skin 23 in order to gain access to the artery 14. The guidewire18 will typically have been placed through the incision 21 and wound 12as part of the surgical procedure which developed the wound 12.

With the guidewire 18 in place, the apparatus 10 can be positioned overthe guidewire 18 so that the distal tip of the catheter 45 follows theguidewire through the incision 21 and the wound 12 into the artery 14.At this point, the graduations 47 on the cannula 30 will provide anindication of the depth of the artery 14 relative to the skin 23.Radiopaque markers on the catheter 45 can be useful to facilitatefluoroscopic guidance to an operative position. The Touhy-Borst valve 65also provides a visual indication of backbleeding which would evidenceproper placement within a blood vessel. The valve 65 can also beprovided with a T-fitting to facilitate injections of X-ray contrastmedia through the catheter 45.

With reference to FIG. 3, it will be noted that the body wall, in thiscase a body wall 161 of the artery 14, has a near side 163 and a farside 165. Since access to the far side 165 of the body wall 161 isseverely limited, it is of particular advantage to the present inventionthat wound closure can be achieved without direct access to the far side165 except through the wound 12.

In the preferred method, the catheter 45 is inserted through the wound12 a distance sufficient that the fingers 118 forming a Mallicotstructure are positioned on the far side 165 of the body wall 161. Thecannula 30 including the needles 90 and 92, remain on the near side 163of the body wall 161. With this orientation, it will be noted that thesuture ends 130, 132 illustrated in FIG. 4 are positioned on the farside 165 while the suture loop 134 is positioned on the near side 163 ofthe body wall 161.

This preferred operative position for the apparatus 10 is achieved byoperation of the handle 37 and associated stationary rings 52. With theapparatus 10 thus disposed, the fingers can be expanded from their firstlow profile state illustrated in FIG. 3 to their second expanded stateillustrated in FIG. 4. Note that this expansion of the fingers 118results in the radial outward movement of the suture portion 159, 160.

With the suture portions 159, 160 appropriately positioned, the needles90, 92 can now be deployed. These needles 90, 92 are initially disposedin their associated bores 85, 87 on the near side 163 of the body wall161. Deployment of the needles 90, 92 is accomplished by moving thefinger ring 54 and associated cylinder 103 distally in the direction ofan arrow 167 in FIG. 5. The distally facing surface 101 of the cylinder103 compresses the spring 98 which in turn exerts a force on the needleflange 94. This force, which is increased with further distal movementof the finger ring 54 against the bias of the spring 96, moves theneedles 90, 92 beyond the distal surface 78 and through needle holes 170and 172 respectively, in the body wall 161. Distal movement of theneedles 90, 92 ceases when the flange 94 bottoms out on the proximalfacing surface 79 of the plug 76.

The needles 90, 92 each have a needle eye 176, 178 respectively, whichin a preferred embodiment is in the form of a French eye. When theneedles 90, 92 are fully extended, these eyes 176, 178 are preferablydisposed on the far side 165 of the body wall 161 and beyond the sutureportions 152, 154. With the suture portions 159, 160 in their radiallyextended position, the needles 90, 92 in their distal-most position, andthe needle eyes 176, 178 facing the suture portions 152, 154, the suture72 can now be manipulated to thread the needles 90, 92.

In a preferred embodiment, this manipulation of the suture 72 isaccomplished by further distal movement of the finger ring 54 to asecond position where the tang 105, riding within the groove 58, engagesthe inclined surface 109 of the flange 107. This engagement of theflange 107 by the tang 105 releases the finger tab 56 from its lockedproximal position. This relieves tension on the element 125 and enablesthe fingers 118 to radially compress naturally as the catheter 45elongates. The radial compression of the fingers 118 moves the sutureportions 159, 160 against the associated needles 90, 92 at a positionproximal to the eyes 176, 178.

Of course with the radial compression of the fingers 118, the distancebetween the adjacent living hinges 121 is reduced. This would normallycause the suture portions 152, 154 to become slack were it not for thesuture tensioning mechanism 138 previously discussed. It will be notedthat as the finger ring 54 is moved distally, the suture tensioningmechanism also moves distally. Since the hole 136 in the catheter 45 isdisposed proximally of the tensioning mechanism 138, the distal movementof the mechanism 138 creates proximal movement of the suture loopthrough the catheter channel 70. This in turn tensions the sutureportions 152 and 154 even as the fingers 118 are radially contracting.

To this point, distal movement of the finger ring 54 has operated todeploy the needles 90, 92 in a first position, and to manipulate thefingers 118 in order to thread the needles in a second position of thefinger ring 54. This manipulation of the fingers 118 in the secondposition is accomplished while tensioning the sutures 72 with themechanism 138.

Further distal movement of the finger ring 54 to a third positionresults in removal of the suture loop 134 from the post 143 of thetensioner 138. This has the effect of releasing the suture loop 134 fromthe apparatus 10 so that it is free to be drawn into the wound 12. Thisfreeing of the suture loop 134 is accomplished as illustrated in FIG. 3Bwhen distal movement of the cylinder 103 brings the tab 141 intoproximity with the projection 145 on the handle 37. This interferingrelationship causes the tab 141 to compress radially inwardly thusforcing the suture loop 134 from the post 143 as illustrated in FIG. 3D.

It will be noted at this point that movement of the finger ring 54 in acommon distal direction operates to perform three sequential steps in amethod for operating the apparatus 10. In a first step associated withfirst distal position of the ring 54, the needles 90, 92 are deployed toa position where they can be threaded. In a second step associated witha second position of the ring 54, the finger tab 56 is released therebypermitting contraction of the fingers 118 to facilitate threading theneedles 90, 92. In a third step associated with a third position of thefinger ring 54, the suture loop 134 is released from the tensioningmechanism 138 to facilitate withdrawal of the apparatus 10.

With the suture portions 152, 154 tensioned radially against the needles90, 92 proximally of the eyes 176, 178, the needles 90,92 can now beretracted. Initially this retraction of the needles 90, 92 causes thetensioned suture portions 159, 160 to enter the eyes 176, 178. Furtherretraction of the needles 90, 92 withdraws the captured suture portions159, 160 through the associated needle holes 170, 172 in the skin 23. Atthis point, both of the suture ends 130, 132, as well as the suture loop134, are disposed on the near side 163 of the wall 161. The apparatus 10can now be withdrawn from the wound 12.

The needles 90, 92 are preferably retracted until the eyes 176, 178enlarged by the presence of the suture portions 152, 154 are biasedagainst the distal surface 78 at the distal end of the cannula 30. Inthis position of the needles 90, 92, illustrated in the enlarged view ofFIG. 6A, the suture ends 130, 132 are trapped between the respectiveneedles 90, 92 and the cannula 30 due to return spring force.

With the suture loop 134 released from the post 143 of the tensioner138, removal of the apparatus 10 will draw the suture portions 159, 160further away from the body wall 161 as illustrated in FIG. 7. Thiscauses the suture loop 134 to be drawn distally through the catheter 45until it exits from between adjacent legs 156, 158 and is drawn throughthe wound 12 to the far side 165 of the body wall 161.

Once the wound closure apparatus 10 has been fully removed from thewound 12, the suture ends 130, 132 can be removed or cut from thefingers 118 and tied with a surgeon's knot in a conventional manner.Such a knot can be pushed through the incision 21 and into proximitywith the wound 12 as illustrated in FIG. 8.

An additional embodiment of the invention is illustrated in FIG. 10 andincludes two needle pairs. The needles 90 and 92 previously discussedform one of the needle pairs while an additional needle pair comprisesneedles 201 and 203. In this case, the four needles 90, 92, 201 and 203are displaced 90° from each other around the distal surface 78 of thecannula 30. The needle deployment (not shown in FIG. 10) can be similarto that previously discussed where the four needles 90, 92, 201 and 203are fixed to the common flange 94 (best illustrated in FIG. 4).

This embodiment of the invention functions to simultaneously apply twosutures to the wound 12. The first suture can be that previouslyreferenced with the numeral 72. This suture can be laced to the suturemanipulating mechanism illustrated in FIG. 9 in the same manner asdiscussed with reference to FIG. 5. A second color-coded suture 205 canalso be laced on to the legs 152-158 of the Mallicot structure in themanner illustrated in FIG. 9.

This suture 205 having a first end 207 and a second end 209 is alsocharacterized by a suture loop portion 210. In a preferred method, theend 207 of the suture 205 is loosely held in the leg 154 of the Mallicotstructure. The suture is then laced through the living hinge 121 and theleg 152 with the suture loop 210 extending into the channel associatedwith the catheter 45. As the suture loop exits this channel, it can bepassed through the living hinge 121 associated with the leg 158.Finally, the end 209 of the second suture 205 can be loosely embedded inthe leg 156.

This configuration for the second suture 205 produces a suture portion212 between the legs 152 and 154 and a second suture portion 214 betweenthe legs 156 and 158. In this manner, the two sutures 72 and 205 canform the four suture portions 159, 160, 212 and 214 for the respectiveneedles 90, 92, 201 and 203. The resulting suture deployment mechanismcan be operated in the manner previously discussed to thread each of thefour needles associated with the embodiment of FIG. 10.

The dual suture embodiment of the suture deployment mechanismillustrated in FIG. 9, can also be used with the two needle embodimentof the apparatus 10 previously discussed. In a preferred method ofoperation, the two needles 90-92 can be operated in the mannerpreviously discussed to capture the suture portions 159 and 160. Thenthe cannula 30 and needles 90, 92 can be rotated 90° to function withrespect to the suture portions 212 and 214. Of course in thisembodiment, means must be provided for rotating the cannula 30, andneedles 90, 92 relative to the legs 152-158 forming the Mallicotstructure.

FIG. 12 illustrates a further embodiment of the wound closure apparatus10. This embodiment includes the cannula 30 and catheter 45, as well asthe fingers 118 and associated suture 72. The illustrated embodimentalso includes the needles 90, 92, but in this case, the needle eyes(previously designated by the reference numerals 176, 178) are notformed as French eyes, but rather as mere slots 221, 223. As compared tothe French eyes previously discussed, the slots 221, 223 can be formedwith a significantly lesser depth. As a result, the needles 90, 92 canprovided with a much smaller diameter.

The embodiment of FIG. 12 provides for effective suture capture with theprovision of suture capture needles 225 and 227. These needles 225 and227 can be provided with a tubular configuration and a telescopingrelationship with the associated needles 90, 92. The distal ends of thesuture capture needles 225, 227 can be sharpened to facilitate theirdeployment through the body wall 17.

Operation of the FIG. 12 embodiment proceeds in the manner previouslydiscussed with the needles 90, 92 being deployed through the body wall17. With the more narrow configuration of the needles 90, 92, this stepof deploying the needles should be more easily accomplished than in theFIG. 5 embodiment. As the suture 72 is manipulated by the fingers 118 inthe manner previously discussed, the suture 72 is drawn into the slots221, 223 of the respective needles 90, 92. At this point, the suturecapture needles 225, 227 can be deployed by moving them distally alongthe associated needles 90, 92. As the distal end of the capture needles225, 227 approach the slots 221, 223, the suture 72 is pinched betweenthe associated needles 90, 225 and 92, 227.

With the suture 72 appropriately captured in the slots 221, 223, theneedles 90, 92 and associated capture needles 225, 227 can be withdrawntoward the cannula 30. Preferably after the needles 90, 92 and 225, 227have cleared the body wall 17, the entire apparatus 10 can be withdrawnfrom the wound 12 as the method of closure continues in the mannerpreviously described.

Given the wide variations in the concept embodied in the foregoingapparatus and methods, one is cautioned not to restrict the invention tothe embodiments which have been specifically disclosed and illustrated,but rather is encouraged to determine the scope of the invention onlywith reference to the following claims.

We claim:
 1. A method for suturing a wound in a body wall having a nearside and a far side, comprising the steps of:providing a wound closureapparatus including a proximal section, a distal section and anintermediate section; inserting the distal section through the woundfrom the near side to the far side of the body wall; deploying a pair ofneedles through the body wall surrounding the wound to form anassociated pair of needle holes; inserting a suture having two ends anda suture loop extending therebetween directly into and through the woundfrom the near side to the far side of the body wall; manipulating thesuture into threading engagement with the needles; withdrawing thethreaded needles through the needle holes to access the ends of thesuture on the near side of the body wall; and withdrawing the distalsection of the apparatus through the wound.
 2. The method recited inclaim 1, wherein the manipulating step includes the steps of moving thesuture to engage the needle on the far side of the wall to thread theneedle.
 3. The method recited in claim 1 further comprising the stepof:tying the ends of the suture to each other to close the wound in thebody wall.
 4. The method recited in claim 1 wherein the providing stepincludes the step of:providing the intermediate section in the form of arigid tube having a proximal end and a distal end; and providing thedistal section in the form of a flexible tube attached to the distal endof the rigid tube.
 5. The method recited in claim 1 wherein thedeploying step includes the steps of:providing a deployment mechanism inthe proximal section of the apparatus; and operating the deploymentmechanism on the near side of the body wall to deploy the needlesthrough the body wall.
 6. A method for suturing a wound formed in tissueof a body wall having a near side and a far side, the method comprisingthe steps of:providing a suture having a first and a second end, and asuture loop extending therebetween; inserting an unthreaded first needleand an unthreaded second needle through the tissue; inserting the firstend and the second end of the suture directly into and through the woundleaving the suture loop on the near side of the body wall; manipulatingthe suture into threading engagement with the needles; withdrawing thethreaded needles and the associated first and second end of the suturethrough the tissue; tensioning at least one of a first and second endsof the suture on the near side of the wall to draw the suture loop tothe far side of the body wall; and tying the first end to the second endof the suture to close the wound formed in the tissue of the body wall.7. The method recited in claim 6 wherein the needles are threadedsubstantially simultaneously.
 8. The method recited in claim 6 furthercomprising the steps of:during the tensioning steps, engaging the sutureloop on the near side of the body wall to tension the first and secondends of the suture on the far side of the body wall; and during thewithdrawing step, disengaging the suture loop on the near side of thebody wall to draw the suture loop to the far side of the body wall.
 9. Awound closure apparatus for suturing a wound in a tissue wall,comprising:a cannula having an axis extending between a proximal end anda distal end; a handle disposed at the proximal end of the cannula; atleast one needle disposed in proximity to the distal end of the cannula,the needle being movable between a proximal position and a distalposition adjacent to the wound to be closed; and a suture manipulatorcarried by the cannula and being insertable directly into and throughthe wound, the manipulator being operable to manipulate the suture intothreading engagement with the needle when the needle is in the distalposition.
 10. The wound closure apparatus recited in claim 9 furthercomprising:a finger tab disposed on the handle and coupled to the suturemanipulator, the tab being movable relative to the handle to operate themanipulator so that the suture moves between a first position and asecond position disposed radially outwardly of the first position. 11.The wound closure apparatus recited in claim 10 wherein:the needle inthe distal position is positioned generally parallel to the axis of thecannula and is disposed generally a first distance from the axis of thecannula; the suture in the first position is positioned generallyparallel to the axis of the cannula and is disposed generally a seconddistance from the axis of the cannula, the second distance being lessthan the first distance; and the suture in the second position ispositioned generally parallel to the axis of the cannula and is disposedgenerally a third distance from the axis of the cannula, the thirddistance being greater than the second distance.